Sunday, 7 July 2013

PERSONAL SAFETY VS PUBLICATION NTPS


The NTPS is the Non-Technical Project Summary that every project manager should submit to the IMB as part of their project authorization application. 
The format and structure of the NTPS is established by the European Commission, and it is a requirement that it is written in language that is easily understood. In addition, the legislation requires that the NTPS should not contain proprietary or confidential information which might identify either the establishment where the study is conducted or the personnel involved. There are several measures that the IMB takes in collaboration with the project manager to ensure the applicant's anonymity and personal safety. 


Guidance on the content of the NTPS and its application form are available here: http://www.imb.ie/EN/Publications/Publications/Nontechnical-project-summary-under-Directive-201063EU.aspx?page=1&tags=113

The IMB has communicated the steps that they follow to ensure personal researchers safety and to ensure compliance with the Dir 10/63/EU. This communication is the response to a concerned researcher whose work is so unique that this researcher can be easily identified in the relatively small irish scientific community: 
Regarding the content of the non-technical project summary and your personal safety, we would like to assure you that we take your concerns very seriously. An extensive peer review is carried out by the Scientific Animal Protection team (as opposed to a single assessor) for every non-technical project summary that is submitted with a project application. We will ensure in so far as possible that the contents of the non-technical project summary do not contain information that will lead to an individual being identified, while also meeting the requirements as set by the Legislation and the European Commission. During the assessment of your project, any changes that we feel are necessary will be sent to you for your review and approval. You will also be given the opportunity to make any additional changes (and express any particular concerns) at this time, before the non-technical project summary is finalised for publication. The non-technical project summary can be reviewed as many times as is required (by both the IMB and the applicant) in order to agree upon a satisfactory version for publication.
Additional precautions taken by the IMB include the following:

(i)    Ensuring that section A of the application form (containing personal information) will not be published.
(ii)   The sections of the non-technical project summary that will be published do not contain identifiable information, such as the primary establishment in which the project will be conducted.  
(iii)  The IMB plan to publish non-technical project summaries once a quarter in ‘batches’ in order to minimise the attention that a single project might otherwise draw.
(iv)  Generic / lay person terminology should be used, particularly in relation to any information that may lead to the applicant being identified (see further information requested below).
If you have particular concerns about the nature of your work that may lead to you being identified, please supply us with the relevant information which we will take into account during the review of your non-technical project summary. Information you may wish to provide should include the specific areas of your project that you feel could lead to your identification, for example;
-          The disease being studied?
-          The procedures being used?
-          The animal model / strain / genetic status that may be used?
If you are the sole researcher in Ireland studying any of the aspects listed above, we will strive to modify your non-technical project summary to ensure that only generic / lay person language is used that will not lead to your identification. Please be as specific as possible in your response to this email. For example you may be the only researcher studying a particular aspect of a certain disease, but other research groups in Ireland may study different aspects of the same disease and your non-technical project summary can be modified accordingly to reduce the risk that you will be identified.
As the publication of non-technical project summaries is a requirement under Article 43 of Directive 2010/63/EU and Regulation 33 of S.I. No. 543 of 2012, we will be unable to approve any project authorisation until the non-technical project summary has been finalised. However we hope that the above information will reassure you and we look forward to hearing back from you on this topic shortly.

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